Senior Project Manager, Clinical Supply

Forecasts plans schedules coordinate and executes ensuring timely availability of investigational drug supplies and related services to clinical sites and depots. Manages key Clinical Supply Chain projects and activities at the protocol level for Phase I-IV clinical trials of increasing complexity. Works under the supervision of Program Manager or Associate Director and directly with mentor.

Responsibilities

• Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources.
• Translates clinical study design into packaging design. Authors the study medication and labeling section of the clinical protocol.
• Develops protocol specific labeling compliant with applicable global regulations.
• Identifies develops communicates and tracks project timelines activities logistics and milestones.
• Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IRT vendors quality assurance clinical team partners etc. to ensure timely availability of clinical supplies.
• Responsible for protocol specific clinical supplies scenario analysis risk management and contingency planning. Forecasts protocol specific bulk drug product requirements including comparator agents ancillary supplies and commodities including overages.
• Participates in cross functional initiatives as drug subject matter expert.
• Leads in function improvement initiatives.

Qualifications :

• Bachelors Degree required preferably in physical science math engineering or pharmacy.
• 3 years total experience in Pharmaceutical industry preferred but not required.
• Must have experience in one of the following areas: Drug Discovery (e.g. Process Chemistry Analytical Chemistry) Drug Development (e.g. formulation) Clinical Operations (e.g. Clinical Project Management) Supply Chain (e.g. Clinical Supplies Project Management) Quality Assurance.
• Proficient in the application of standard business requirements (for example SOPs Global Regulations OEC).
• Must have understanding of importance of compliance in a regulated environment and be capable of applying this knowledge to improve current processes.
• Capable of representing CDSM as participant in and contributor to cross functional initiatives.
• Ability to work collaboratively across departments/functions and interact in a tactful professional and effective manner.
• Ability to manage and prioritize multiple tasks under tight deadlines and high pressure.
• Strong problem solving and Project Management skills.
• Strong communication skills (both written and oral).

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of  any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time